Elizabeth S. Elson

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Taking a step toward completing a requirement imposed by the Affordable Care Act, the federal government has proposed regulations that would create an administrative dispute resolution (“ADR”) process to resolve disputes between 340B Program covered entities and drug manufacturers. As proposed, the ADR process would be available for covered entities to submit claims that they have been charged for covered outpatient drugs amounts higher than the 340B Program ceiling price, and for drug manufacturers to claim…
Since our last 340B Drug Pricing Program (340B Program) update, the U.S. Centers for Medicare & Medicaid Services (CMS) has issued two regulations, the final Medicaid managed care regulation and a proposed update to the Medicare outpatient prospective payment schedule to implement new site neutrality requirements, that impact the 340B Program.  Providers participating in the 340B Program (covered entities), as well as their contract pharmacies and other stakeholders such as drug manufacturers, state Medicaid…
Please note, Cheryl Storey, CPA with Moss Adams LLP is also a co-author of this post. CMS issued its Outpatient Prospective Payment System (“OPPS”) Proposed Rule for 2017 (the “Proposed Rule”) on July 6, 2016. The Proposed Rule will  be published in the Federal Register on July 14, 2016. One highly-anticipated section of the Proposed Rule is the implementation of legislations known as Section 603 of the Bipartisan Budget Act of 2015 (“BiBA 603”), which…
The new year has already gotten off to a busy start for health care providers that participate in the 340B Drug Pricing Program (“340B Program”) and government agencies that reimburse these providers. Following on the heels of the publication of a Medicaid Covered Outpatient Drug Final Rule (“Final Rule”), the Centers for Medicare and Medicaid Services (“CMS”) recently issued a guidance letter discussing implementation of the Final Rule and informing state Medicaid directors that, under…
The influential Medicare Payment Advisory Commission (MedPAC) has voted to recommend to Congress in its March report that Medicare Part B drug payment rates for 340B drugs be reduced by 10 percent for hospitals participating in the 340B Drug Pricing Program (340B Program). Currently, hospitals are paid the same rate by Medicare for drugs whether or not the drugs are purchased through the 340B Program. MedPAC will also recommend that program savings from this payment…
The Centers for Medicare and Medicaid Services (CMS) has approved a new section 1115 Medicaid demonstration for the state of California. Under the demonstration, the California Department of Health Care Services (DHCS) will develop and redesign components of its Medicaid delivery system consistent with the approved terms and conditions, creating significant changes to California’s Medicaid program, entitled Medi-Cal. The new demonstration, entitled “Medi-Cal 2020,” is authorized for a five-year period from January 1, 2016…
A federal court vacated the Department of Health and Human Services’ (HHS) Orphan Dug Rule that had allowed certain 340B Drug Pricing Program (340B Program) hospital covered entities to receive discounted prices when purchasing orphan drugs for a non-orphan use. In addition to its significant financial impact on hospital covered entities subject to the rule, the decision’s discussion of the limitations on HHS’ rulemaking authority under the 340B Program could pave the way for future…
Foley has scheduled a call on Thursday, September 24, 2015 at 8am PST/10am CST/11am EST to convene 340B Program covered entities that may be interested in forming a “coalition” to develop a response to HHS/HRSA’s recently proposed comprehensive 340B Program guidance, beginning with (but not necessarily limited to) the preparation of comments on the guidance. Interested covered entities are invited to attend this free “kickoff” call.…
The Department of Health and Human Services (HHS) released its proposed 340B Drug Pricing Program Omnibus Guidance (Omnibus Guidance) on August 28, 2015. The Omnibus Guidance offers comprehensive – and, in some cases, new – guidance for 340B Drug Pricing Program (340B Program) covered entities (including providers such as disproportionate share hospitals, critical access hospitals, and federally qualified health centers), participating drug manufacturers, and other stakeholders, including pharmacies that may contract with covered entities for…